EP0904099B1 - Pharmaceutical formulation containing human growth hormone, histidine and a non-ionic detergent - Google Patents
Pharmaceutical formulation containing human growth hormone, histidine and a non-ionic detergent Download PDFInfo
- Publication number
- EP0904099B1 EP0904099B1 EP97918073A EP97918073A EP0904099B1 EP 0904099 B1 EP0904099 B1 EP 0904099B1 EP 97918073 A EP97918073 A EP 97918073A EP 97918073 A EP97918073 A EP 97918073A EP 0904099 B1 EP0904099 B1 EP 0904099B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- growth hormone
- hgh
- formulation
- amount
- histidine
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
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Classifications
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- A—HUMAN NECESSITIES
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- A61P5/10—Drugs for disorders of the endocrine system of the posterior pituitary hormones, e.g. oxytocin, ADH
Definitions
- the kinetics of degradation depend on temperature, pH and various additives or adjuvants in the hGH formulation.
- the pH of the formulation may be adjusted by adding an acid which has no adverse effect on the growth hormone, preferably a physiologically acceptable acid, e.g. a mineral acid such as hydrochloric acid, sulphuric acid or nitric acid, or an organic acid such as acetic acid or citric acid.
- a physiologically acceptable acid e.g. a mineral acid such as hydrochloric acid, sulphuric acid or nitric acid, or an organic acid such as acetic acid or citric acid.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Epidemiology (AREA)
- Endocrinology (AREA)
- Physical Education & Sports Medicine (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Rheumatology (AREA)
- Diabetes (AREA)
- Immunology (AREA)
- Dermatology (AREA)
- Reproductive Health (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Neurology (AREA)
- Pregnancy & Childbirth (AREA)
- Gynecology & Obstetrics (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DK97918073T DK0904099T3 (da) | 1996-04-24 | 1997-04-24 | Farmaceutisk formulering, der indeholder humant væksthormon, histidin og et ikke-ionisk detergent |
| EP05110701A EP1629832A1 (en) | 1996-04-24 | 1997-04-24 | A pharmaceutical formulation comprising human growth hormone, an amino acid and a non-ionic detergent |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DK49096 | 1996-04-24 | ||
| DK49096 | 1996-04-24 | ||
| PCT/DK1997/000184 WO1997039768A1 (en) | 1996-04-24 | 1997-04-24 | A pharmaceutical formulation containing growth hormone, an amino acid and a non-ionic detergent |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP05110701A Division EP1629832A1 (en) | 1996-04-24 | 1997-04-24 | A pharmaceutical formulation comprising human growth hormone, an amino acid and a non-ionic detergent |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| EP0904099A1 EP0904099A1 (en) | 1999-03-31 |
| EP0904099B1 true EP0904099B1 (en) | 2005-11-16 |
Family
ID=8094154
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP05110701A Withdrawn EP1629832A1 (en) | 1996-04-24 | 1997-04-24 | A pharmaceutical formulation comprising human growth hormone, an amino acid and a non-ionic detergent |
| EP97918073A Expired - Lifetime EP0904099B1 (en) | 1996-04-24 | 1997-04-24 | Pharmaceutical formulation containing human growth hormone, histidine and a non-ionic detergent |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP05110701A Withdrawn EP1629832A1 (en) | 1996-04-24 | 1997-04-24 | A pharmaceutical formulation comprising human growth hormone, an amino acid and a non-ionic detergent |
Country Status (20)
| Country | Link |
|---|---|
| US (1) | US20020077461A1 (pt) |
| EP (2) | EP1629832A1 (pt) |
| JP (2) | JP4176834B2 (pt) |
| KR (1) | KR20000010630A (pt) |
| CN (1) | CN1130223C (pt) |
| AT (1) | ATE309819T1 (pt) |
| AU (1) | AU733592B2 (pt) |
| BR (1) | BR9708858A (pt) |
| CA (1) | CA2252535C (pt) |
| CZ (1) | CZ298292B6 (pt) |
| DE (1) | DE69734653T2 (pt) |
| DK (1) | DK0904099T3 (pt) |
| ES (1) | ES2253774T3 (pt) |
| HU (1) | HU229868B1 (pt) |
| IL (2) | IL126463A0 (pt) |
| NO (1) | NO323360B1 (pt) |
| PL (1) | PL188222B1 (pt) |
| RU (1) | RU2236250C2 (pt) |
| UA (1) | UA66758C2 (pt) |
| WO (1) | WO1997039768A1 (pt) |
Families Citing this family (36)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5981485A (en) * | 1997-07-14 | 1999-11-09 | Genentech, Inc. | Human growth hormone aqueous formulation |
| KR100491282B1 (ko) | 1996-07-24 | 2005-05-24 | 워너-램버트 캄파니 엘엘씨 | 통증 치료용 이소부틸가바 및 그의 유도체 |
| ES2230727T3 (es) * | 1997-11-12 | 2005-05-01 | Alza Corporation | Procedimiento de administracion dermal de polipeptidos. |
| GB9803448D0 (en) * | 1998-02-18 | 1998-04-15 | Pharma Mar Sa | Pharmaceutical formulation |
| JP4711520B2 (ja) * | 2000-03-21 | 2011-06-29 | 日本ケミカルリサーチ株式会社 | 生理活性ペプチド含有粉末 |
| CA2418960A1 (en) | 2000-08-07 | 2002-02-14 | Inhale Therapeutic Systems, Inc. | Inhaleable spray dried 4-helix bundle protein powders having minimized aggregation |
| JP4949828B2 (ja) * | 2003-03-18 | 2012-06-13 | アレス トレーディング ソシエテ アノニム | 溶液中での成長ホルモンの安定化 |
| JP4909071B2 (ja) * | 2003-03-24 | 2012-04-04 | プルーローメッド， インコーポレイテッド | 逆感熱性ポリマーを使用する一時的な塞栓形成 |
| DE10333317A1 (de) * | 2003-07-22 | 2005-02-17 | Biotecon Therapeutics Gmbh | Formulierung für Proteinarzneimittel ohne Zusatz von humanem Serumalbumin (HSA) |
| WO2005046438A2 (en) * | 2003-11-06 | 2005-05-26 | Pluromed, Inc. | Internal clamp for surgical procedures |
| JP4845741B2 (ja) * | 2003-12-23 | 2011-12-28 | ファルマシア コーポレーション | 安定な成長ホルモン液体製剤 |
| MXPA06011029A (es) * | 2004-04-07 | 2007-01-25 | Ares Trading Sa | Formulacion liquida de hormona del crecimiento. |
| ZA200704928B (en) * | 2004-12-22 | 2009-04-29 | Ambrx Inc | Formulations of human growth hormone comprising a non-naturally encoded amino acid |
| KR101224781B1 (ko) * | 2004-12-22 | 2013-01-21 | 암브룩스, 인코포레이티드 | 비천연적으로 코딩된 아미노산을 포함하는 인간 성장호르몬의 조제물 |
| KR20070090023A (ko) * | 2004-12-22 | 2007-09-04 | 암브룩스, 인코포레이티드 | 변형 인간 성장 호르몬 |
| KR20080038391A (ko) | 2005-08-30 | 2008-05-06 | 노보 노르디스크 헬스 케어 악티엔게젤샤프트 | 페그화 성장 호르몬의 액체 제제 |
| WO2007033427A1 (en) * | 2005-09-23 | 2007-03-29 | Metabolic Pharmaceuticals Limited | Stabilisation of peptides with basic amino acids |
| CN1939534B (zh) * | 2005-09-27 | 2010-12-01 | 长春金赛药业股份有限公司 | 含有人生长激素或人粒细胞巨噬细胞刺激因子的用于治疗损伤和溃疡的外用制剂 |
| CN101505789A (zh) * | 2006-07-06 | 2009-08-12 | 株式会社大熊 | 稳定的人生长激素液体制剂 |
| US9175061B2 (en) | 2006-07-07 | 2015-11-03 | Novo Nordisk Health Care Ag | Protein conjugates and methods for their preparation |
| US8071544B2 (en) * | 2006-12-18 | 2011-12-06 | Althea Technologies, Inc. | Crystallized recombinant human growth factor formulations |
| MX345736B (es) | 2010-01-22 | 2017-02-14 | Novo Nordisk Healthcare Ag | Hormonas de crecimiento con eficacia in vivo prolongada. |
| CA2787895A1 (en) | 2010-01-22 | 2011-07-28 | Novo Nordisk Health Care Ag | Stable growth hormone compounds |
| KR101337797B1 (ko) * | 2010-07-14 | 2013-12-06 | 한미사이언스 주식회사 | 지속형 인간 성장 호르몬 결합체 액상 제제 |
| CA2811709C (en) * | 2010-09-21 | 2019-08-13 | Ferring B.V. | Improved process for production of recombinant human growth hormone |
| US9216219B2 (en) * | 2012-06-12 | 2015-12-22 | Novartis Ag | Anti-BAFFR antibody formulation |
| SG10201805807PA (en) | 2012-06-26 | 2018-08-30 | Del Mar Pharmaceuticals | Methods for treating tyrosine-kinase-inhibitor-resistant malignancies in patients with genetic polymorphisms or ahi1 dysregulations or mutations employing dianhydrogalactitol, diacetyldianhydrogalactitol, dibromodulcitol, or analogs or derivatives thereof |
| JP6464145B2 (ja) | 2013-04-05 | 2019-02-06 | ノヴォ・ノルディスク・ヘルス・ケア・アーゲー | 成長ホルモン化合物製剤 |
| KR20160061911A (ko) | 2013-04-08 | 2016-06-01 | 데니스 엠. 브라운 | 최적하 투여된 화학 화합물의 치료 효과 |
| KR20160099081A (ko) | 2013-07-26 | 2016-08-19 | 업데이트 파마 인코포레이트 | 비산트렌의 치료 효과 개선용 조합 방법 |
| CA2925416A1 (en) * | 2013-09-27 | 2015-04-02 | Hanmi Pharm. Co., Ltd. | Sustained type human growth hormone preparation |
| US9119832B2 (en) | 2014-02-05 | 2015-09-01 | The Regents Of The University Of California | Methods of treating mild brain injury |
| US20170121385A1 (en) | 2015-10-28 | 2017-05-04 | Oxeia Biopharmaceuticals, Inc. | Methods of treating neurodegenerative conditions |
| US11932699B2 (en) | 2017-09-07 | 2024-03-19 | Jcr Pharmaceuticals Co., Ltd. | Aqueous pharmaceutical composition |
| CN117771250A (zh) | 2018-06-29 | 2024-03-29 | 因赛特公司 | Axl/mer抑制剂的制剂 |
| CN115634284A (zh) * | 2022-10-31 | 2023-01-24 | 景泽生物医药(合肥)有限公司 | 一种促性腺激素冻干制剂及其制备方法 |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5096885A (en) * | 1988-04-15 | 1992-03-17 | Genentech, Inc. | Human growth hormone formulation |
| DE69232847T2 (de) * | 1991-12-20 | 2003-09-11 | Novo Nordisk As | Stabilisierte pharmazeutische formulierung, die wachstumshormon und histidin enthält |
| DK204791D0 (da) * | 1991-12-20 | 1991-12-20 | Novo Nordisk As | Hidtil ukendt farmaceutisk praeparat |
| AU686567C (en) * | 1992-07-31 | 2002-08-08 | Genentech Inc. | Human growth hormone aqueous formulation |
-
1997
- 1997-04-23 US US08/842,293 patent/US20020077461A1/en not_active Abandoned
- 1997-04-24 CA CA002252535A patent/CA2252535C/en not_active Expired - Lifetime
- 1997-04-24 HU HU9902476A patent/HU229868B1/hu unknown
- 1997-04-24 UA UA98105593A patent/UA66758C2/xx unknown
- 1997-04-24 AU AU26343/97A patent/AU733592B2/en not_active Expired
- 1997-04-24 BR BR9708858A patent/BR9708858A/pt not_active Application Discontinuation
- 1997-04-24 KR KR1019980708535A patent/KR20000010630A/ko active Search and Examination
- 1997-04-24 ES ES97918073T patent/ES2253774T3/es not_active Expired - Lifetime
- 1997-04-24 AT AT97918073T patent/ATE309819T1/de active
- 1997-04-24 DK DK97918073T patent/DK0904099T3/da active
- 1997-04-24 IL IL12646397A patent/IL126463A0/xx active IP Right Grant
- 1997-04-24 EP EP05110701A patent/EP1629832A1/en not_active Withdrawn
- 1997-04-24 EP EP97918073A patent/EP0904099B1/en not_active Expired - Lifetime
- 1997-04-24 CZ CZ0320798A patent/CZ298292B6/cs not_active IP Right Cessation
- 1997-04-24 CN CN97194040A patent/CN1130223C/zh not_active Expired - Lifetime
- 1997-04-24 JP JP53762297A patent/JP4176834B2/ja not_active Expired - Lifetime
- 1997-04-24 DE DE69734653T patent/DE69734653T2/de not_active Expired - Lifetime
- 1997-04-24 PL PL97329386A patent/PL188222B1/pl unknown
- 1997-04-24 WO PCT/DK1997/000184 patent/WO1997039768A1/en active IP Right Grant
- 1997-04-24 RU RU98121135/15A patent/RU2236250C2/ru active
-
1998
- 1998-10-04 IL IL126463A patent/IL126463A/en not_active IP Right Cessation
- 1998-10-23 NO NO19984951A patent/NO323360B1/no not_active IP Right Cessation
-
2008
- 2008-06-03 JP JP2008145780A patent/JP2008231124A/ja not_active Withdrawn
Also Published As
| Publication number | Publication date |
|---|---|
| HUP9902476A2 (hu) | 2000-11-28 |
| CN1130223C (zh) | 2003-12-10 |
| NO323360B1 (no) | 2007-04-10 |
| AU2634397A (en) | 1997-11-12 |
| NO984951L (no) | 1998-10-23 |
| WO1997039768A1 (en) | 1997-10-30 |
| CA2252535C (en) | 2009-06-23 |
| DK0904099T3 (da) | 2006-03-06 |
| CZ298292B6 (cs) | 2007-08-15 |
| PL329386A1 (en) | 1999-03-29 |
| JP2000508665A (ja) | 2000-07-11 |
| DE69734653D1 (de) | 2005-12-22 |
| ATE309819T1 (de) | 2005-12-15 |
| KR20000010630A (ko) | 2000-02-25 |
| BR9708858A (pt) | 1999-08-03 |
| JP2008231124A (ja) | 2008-10-02 |
| CN1216472A (zh) | 1999-05-12 |
| HU229868B1 (en) | 2014-10-28 |
| EP0904099A1 (en) | 1999-03-31 |
| IL126463A0 (en) | 1999-08-17 |
| IL126463A (en) | 2007-06-17 |
| HUP9902476A3 (en) | 2000-12-28 |
| PL188222B1 (pl) | 2004-12-31 |
| EP1629832A1 (en) | 2006-03-01 |
| NO984951D0 (no) | 1998-10-23 |
| ES2253774T3 (es) | 2006-06-01 |
| JP4176834B2 (ja) | 2008-11-05 |
| AU733592B2 (en) | 2001-05-17 |
| CZ320798A3 (cs) | 1999-03-17 |
| UA66758C2 (en) | 2004-06-15 |
| CA2252535A1 (en) | 1997-10-30 |
| DE69734653T2 (de) | 2006-08-10 |
| RU2236250C2 (ru) | 2004-09-20 |
| US20020077461A1 (en) | 2002-06-20 |
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